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FDA 510(k)

ISOLATION KIT

K-Number: K770381 · 1977-04-05

ApplicantAmerican Hospital Supply Corp.
Decision Date1977-04-05
Product CodeLDQ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ISOLATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Hospital Supply Corp.. It received FDA 510(k) clearance on 1977-04-05 under 510(k) number K770381. The device is classified under product code LDQ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLATION KIT?

ISOLATION KIT is a medical device that received FDA 510(k) clearance on 1977-04-05. The listed applicant is American Hospital Supply Corp.. The 510(k) number is K770381.

When did ISOLATION KIT receive FDA 510(k) clearance?

ISOLATION KIT received FDA 510(k) clearance on 1977-04-05, under 510(k) number K770381.

Who is the listed applicant for ISOLATION KIT?

The FDA 510(k) record lists American Hospital Supply Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOLATION KIT?

The FDA product code for ISOLATION KIT is LDQ.

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Other records listing American Hospital Supply Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K854739AMERICAN STERILE SURGICAL ABSORBENT TOWELK854759AMERICAN STERILE MAYO STAND TRAYK832826AAP DOSIMETRY RELEASE OR BASIN SETSK830546DOSIMETRIC RELEASEK822990CONVERTORS PRIMARY WOUND DRESSING IIK830343CONTAINER W/PRIMING SOLUTION

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Related Devices (Code: LDQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K993797EC-7701 FLUID WARMING CABINETEnthermics Medical Systems, Inc.K992258HOT SHOT FLUID WARMER IV FLUIDSInfra-Med Technologies, Inc.K981032PIV SYSTEMMedical Solutions, Inc.K973747CONTROLLED TEMPERATURE CABINET SYSTEMSmithK955661ACU-HALTGlederer & Co., Inc.K955776ACU-LABGlederer & Co., Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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